Our contracted CMO has successfully completed the scale-up batch on the product. The three exhibit batches are scheduled for the next 3 weeks. This means that we are on target to file our ANDA with the FDA by 2Q2020, which aligns us with our projected timeline to market!
Our other contracted CMO had a recent successful US-FDA inspection which will lead to a smooth approval of our other manufactured drug. They have met the US statutory required regulations.
The FDA dossier for submission is in the preparation process for our licensed drug and on its way to being complete. After review from notable regulatory consulting firms that represent big pharma organizations, we have been given the thumbs up that our submission will most likely be approved by the FDA.
top of page
bottom of page